MEDICATION GUIDEHADLIMATM (HAD-lee-mah)(adalimumab-bwwd)
injection, for subcutaneous use
Read the Medication Guide that comes with HADLIMA before you start taking it and eachtime you get a refill. There may be new information. This Medication Guide does not take theplace of talking with your doctor about your medical condition or treatment.
What is the most important information I should know about HADLIMA?
HADLIMA is a medicine that affects your immune system. HADLIMA can lower the ability ofyour immune system to fight infections. Serious infections have happened in people
taking adalimumab products. These serious infections include tuberculosis (TB) andinfections caused by viruses, fungi or bacteria that have spread throughout the body.
Some people have died from these infections.
Your doctor should test you for TB before starting HADLIMA.
Your doctor should check you closely for signs and symptoms of TB during treatment
with HADLIMA.
You should not start taking HADLIMA if you have any kind of infection unless your doctor
says it is okay.
Before starting HADLIMA, tell your doctor if you:think you have an infection or have symptoms of an infection such as:
fever, sweats, or chills
muscle aches
coughshortness of breathblood in phlegm

warm, red, or painful skin or sores on
your body
diarrhea or stomach pain
burning when you urinate or urinate
more often than normal
feel very tired
weight loss

are being treated for an infection.
get a lot of infections or have infections that keep coming back.
have diabetes.
have TB, or have been in close contact with someone with TB.
were born in, lived in, or traveled to countries where there is more risk for getting TB. Ask
your doctor if you are not sure.
live or have lived in certain parts of the country (such as the Ohio and Mississippi Rivervalleys) where there is an increased risk for getting certain kinds of fungal infections(histoplasmosis, coccidioidomycosis, or blastomycosis). These infections may happen or
become more severe if you use HADLIMA. Ask your doctor if you do not know if you
have lived in an area where these infections are common.
have or have had hepatitis B.
use the medicine ORENCIA (abatacept), KINERET (anakinra), RITUXAN (rituximab),IMURAN (azathioprine), or PURINETHOL (6–mercaptopurine, 6-MP).
are scheduled to have major surgery
After starting HADLIMA, call your doctor right away if you have an infection, or any signof an infection.
HADLIMA can make you more likely to get infections or make any infection that you may
have worse.
CancerFor children and adults taking Tumor Necrosis Factor (TNF)-blockers, including
HADLIMA, the chances of getting cancer may increase.
There have been cases of unusual cancers in children, teenagers, and young adults
using TNF-blockers.

People with rheumatoid arthritis (RA), especially more serious RA, may have a higher
chance for getting a kind of cancer called lymphoma.
If you use TNF blockers including HADLIMA, your chance of getting two types of skincancer may increase (basal cell cancer and squamous cell cancer of the skin). Thesetypes of cancer are generally not life-threatening if treated. Tell your doctor if you have abump or open sore that does not heal.
Some people receiving TNF blockers including HADLIMA developed a rare type ofcancer called hepatosplenic T-cell lymphoma. This type of cancer often results in death.
Most of these people were male teenagers or young men. Also, most people were being
treated for Crohn’s disease or ulcerative colitis with another medicine called IMURAN®
(azathioprine) or PURINETHOL® (6-mercaptopurine, 6–MP).
What is HADLIMA?
HADLIMA is a medicine called a Tumor Necrosis Factor (TNF) blocker. HADLIMA is used:
to reduce the signs and symptoms of:moderate to severe rheumatoid arthritis (RA) in adults. HADLIMA can be usedalone, with methotrexate, or with certain other medicines.
moderate to severe polyarticular juvenile idiopathic arthritis (JIA) in children 2years and older. HADLIMA can be used alone, or with methotrexate.
psoriatic arthritis (PsA) in adults. HADLIMA can be used alone or with certain othermedicines.
ankylosing spondylitis (AS) in adults.
moderate to severe hidradenitis suppurativa (HS) in adults.
to treat moderate to severe Crohn’s disease (CD) in adults and children 6 years ofage and older.
to treat moderate to severe ulcerative colitis (UC) in adults. It is not known if
adalimumab products are effective in people who stopped responding to or could not
tolerate TNF-blocker medicines.
to treat moderate to severe chronic (lasting a long time) plaque psoriasis (Ps) in
adults who have the condition in many areas of their body and who may benefit fromtaking injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet
light alone or with pills).
to treat non-infectious intermediate, posterior, and panuveitis in adults
What should I tell my doctor before taking HADLIMA?
HADLIMA may not be right for you. Before starting HADLIMA, tell your doctor about all of
your medical conditions, including if you:have an infection. See “What is the most important information I should know about
HADLIMA?”
have or have had cancer.
have any numbness or tingling or have a disease that affects your nervous system suchas multiple sclerosis or Guillain-Barré syndrome.
have or had heart failure.
have recently received or are scheduled to receive a vaccine. You may receive vaccines,except for live vaccines while using HADLIMA. Children should be brought up to datewith all vaccines before starting HADLIMA.
are allergic to HADLIMA or to any of its ingredients. See the end of this Medication Guide
for a list of ingredients in HADLIMA.
are pregnant or plan to become pregnant, breastfeeding or plan to breastfeed. You andyour doctor should decide if you should take HADLIMA while you are pregnant orbreastfeeding.
have a baby and you were using HADLIMA during your pregnancy. Tell your baby’s
doctor before your baby receives any vaccines.
Tell your doctor about all the medicines you take, including prescription and over-thecounter medicines, vitamins, and herbal supplements.
Especially tell your doctor if you use:

ORENCIA (abatacept), KINERET (anakinra), REMICADE (infliximab), ENBREL(etanercept), CIMZIA (certolizumab pegol) or SIMPONI (golimumab), because you
should not use HADLIMA while you are also using one of these medicines.
RITUXAN (rituximab). Your doctor may not want to give you HADLIMA if you havereceived RITUXAN (rituximab) recently.
IMURAN (azathioprine) or PURINETHOL (6–mercaptopurine, 6-MP).
Keep a list of your medicines with you to show your doctor and pharmacist each time
you get a new medicine.
How should I take HADLIMA?
HADLIMA is given by an injection under the skin. Your doctor will tell you how often to
take an injection of HADLIMA. This is based on your condition to be treated. Do notinject HADLIMA more often than you were prescribed.
See the Instructions for Use inside the carton for complete instructions for the right way
to prepare and inject HADLIMA.
Make sure you have been shown how to inject HADLIMA before you do it yourself. You
can call your doctor or 1-844-674-3200 if you have any questions about giving yourself
an injection. Someone you know can also help you with your injection after they havebeen shown how to prepare and inject HADLIMA.
Do not try to inject HADLIMA yourself until you have been shown the right way to givethe injections. If your doctor decides that you or a caregiver may be able to give yourinjections of HADLIMA at home, you should receive training on the right way to prepare
and inject HADLIMA.
Do not miss any doses of HADLIMA unless your doctor says it is okay. If you forget totake HADLIMA, inject a dose as soon as you remember. Then, take your next dose atyour regular scheduled time. This will put you back on schedule. In case you are not surewhen to inject HADLIMA, call your doctor or pharmacist.
If you take more HADLIMA than you were told to take, call your doctor.
What are the possible side effects of HADLIMA?
HADLIMA can cause serious side effects, including:See “What is the most important information I should know about HADLIMA?”
Serious Infections.
Your doctor will examine you for TB and perform a test to see if you have TB. If yourdoctor feels that you are at risk for TB, you may be treated with medicine for TB before
you begin treatment with HADLIMA and during treatment with HADLIMA. Even if your TB
test is negative your doctor should carefully monitor you for TB infections while you aretaking HADLIMA. People who had a negative TB skin test before receiving adalimumabproducts have developed active TB. Tell your doctor if you have any of the following
symptoms while taking or after taking HADLIMA:
cough that does not go away
weight loss
low grade feverloss of body fat and muscle (wasting)
Hepatitis B infection in people who carry the virus in their blood.
If you are a carrier of the hepatitis B virus (a virus that affects the liver), the virus canbecome active while you use HADLIMA. Your doctor should do blood tests before you
start treatment, while you are using HADLIMA, and for several months after you stoptreatment with HADLIMA. Tell your doctor if you have any of the following symptoms of a
possible hepatitis B infection:muscle aches
clay-colored bowel movements
feel very tired
feverdark urine
chillsskin or eyes look yellow
stomach discomfort
little or no appetite
skin rashvomiting

Allergic reactions. Allergic reactions can happen in people who use HADLIMA. Call
your doctor or get medical help right away if you have any of these symptoms of aserious allergic reaction:
hives
swelling of your face, eyes, lips or mouth
trouble breathing
Nervous system problems. Signs and symptoms of a nervous system problem include:numbness or tingling, problems with your vision, weakness in your arms or legs, anddizziness.
Blood problems. Your body may not make enough of the blood cells that help fightinfections or help to stop bleeding. Symptoms include a fever that does not go away,
bruising or bleeding very easily, or looking very pale.
New heart failure or worsening of heart failure you already have. Call your doctor
right away if you get new worsening symptoms of heart failure while taking HADLIMA,
including:shortness of breathswelling of your ankles or feetsudden weight gain
Immune reactions including a lupus-like syndrome. Symptoms include chest
discomfort or pain that does not go away, shortness of breath, joint pain, or a rash on
your cheeks or arms that gets worse in the sun. Symptoms may improve when you stop
HADLIMA.
Liver problems. Liver problems can happen in people who use TNF-blocker medicines.
These problems can lead to liver failure and death. Call your doctor right away if you
have any of these symptoms:
feel very tiredskin or eyes look yellow
poor appetite or vomiting
pain on the right side of your stomach (abdomen)
Psoriasis. Some people using adalimumab products had new psoriasis or worsening ofpsoriasis they already had. Tell your doctor if you develop red scaly patches or raised
bumps that are filled with pus. Your doctor may decide to stop your treatment withHADLIMA.
Call your doctor or get medical care right away if you develop any of the above
symptoms. Your treatment with HADLIMA may be stopped.
The most common side effects of HADLIMA include:injection site reactions: redness, rash, swelling, itching, or bruising. These symptoms
usually will go away within a few days. Call your doctor right away if you have pain,
redness or swelling around the injection site that does not go away within a few days orgets worse.
upper respiratory infections (including sinus infections)headaches
rash
These are not all the possible side effects with HADLIMA. Tell your doctor if you have anyside effect that bothers you or that does not go away. Ask your doctor or pharmacist for moreinformation.
Call your doctor for medical advice about side effects. You may report side effects to the FDA
at 1-800-FDA-1088.
How should I store HADLIMA?
Store HADLIMA in the refrigerator at 36ºF to 46ºF (2ºC to 8ºC). Store HADLIMA in theoriginal carton until use to protect it from light.
Do not freeze HADLIMA. Do not use HADLIMA if frozen, even if it has been thawed.
Refrigerated HADLIMA may be used until the expiration date printed on the HADLIMA
carton, autoinjector or prefilled syringe. Do not use HADLIMA after the expiration date.

If needed, for example when you are traveling, you may also store HADLIMA PushTouchor prefilled syringe at room temperature up to 77°F (25°C) for up to 14 days. StoreHADLIMA PushTouch or prefilled syringe in the original carton until use to protect it fromlight.
Throw away HADLIMA PushTouch or prefilled syringe if it has been kept at room
temperature and not been used within 14 days.
Record the date you first remove HADLIMA PushTouch or prefilled syringe from therefrigerator in the spaces provided on the carton.
Do not store HADLIMA in extreme heat or cold.
The solution should be clear and colorless to pale brown. Do not use an autoinjector orprefilled syringe if the liquid is cloudy, discolored, or has flakes or particles in it.
Do not drop or crush HADLIMA. The prefilled syringe is glass.
Keep HADLIMA, injection supplies, and all other medicines out of the reach ofchildren.
General information about the safe and effective use of HADLIMA
Medicines are sometimes prescribed for purposes other than those listed in a Medication
Guide. Do not use HADLIMA for a condition for which it was not prescribed. Do not give
HADLIMA to other people, even if they have the same condition. It may harm them.
This Medication Guide summarizes the most important information about HADLIMA. If you
would like more information, talk with your doctor. You can ask your doctor or pharmacist for
information about HADLIMA that is written for health professionals. For more information go
to www.HADLIMA.com or call Organon LLC, a subsidiary of Organon & Co., at 1-844-6743200.
What are the ingredients in HADLIMA?
Active ingredient: adalimumab-bwwd
HADLIMA PushTouch 40 mg/0.8 mL, HADLIMA 40 mg/0.8 mL prefilled syringe, andHADLIMA 40 mg/0.8 mL institutional use vial:
Inactive ingredients: citric acid monohydrate, L-histidine, L-histidine hydrochloridemonohydrate, polysorbate 20, sodium citrate dihydrate, sorbitol, and Water for Injection, USP.
HADLIMA PushTouch 40 mg/0.4 mL and HADLIMA 40 mg/0.4 mL prefilled syringe:
Inactive ingredients: L-histidine, L-histidine hydrochloride monohydrate, mannitol,
polysorbate 20, sodium phosphate dibasic heptahydrate, sodium phosphate monobasicmonohydrate, sodium succinate dibasic, succinic acid, and Water for Injection, USP

Manufactured by: Samsung Bioepis Co., Ltd., 76, Songdogyoyuk-ro, Yeonsu-gu, Incheon, 21987, Republic ofKorea
U.S. License No. 2046

The trademarks above are owned by their respective owners.
This Medication Guide has been approved by the U.S. Food and Drug Administration.

Revised: 7/2023